The Mayo Clinic and Yale University are working with the FDA to study the reliability of mobile health devices in capturing functional capacity and quality of life data for heart failure patients after their release from the hospital.
Study participants will be monitored at home using two wearable devices over a period of 60 days: Biovotion’s Everion and Apple’s Apple Watch Series 4.
The FDA released a draft guidance in June about endpoints for heart failure drug development. The agency believes there’s a need for alternative heart failure endpoints related to symptoms and a patient’s state of physical functioning. The university said new heart failure therapy studies may be able to use the device data as surrogate endpoints.